Can an EpiPen Fail? What Happens if It Does?

Some people have severe allergic reactions to certain foods and medications, such as nuts, shellfish, or antibiotics. Other severe allergy catalysts include bee stings or certain dyes or chemicals. An allergic reaction can come on quickly after exposure to the allergen.

Because of this, doctors often recommend that these individuals carry an epinephrine auto-injector—commonly referred to by the brand name EpiPen—everywhere they go. This way, the individual can obtain the medicine they need to combat a serious allergic reaction as quickly as possible.

Unfortunately, EpiPens can fail in several ways, resulting in an individual not getting the medication they need to stop the allergic reaction. In fact, the U.S. Food & Drug Administration—the federal agency tasked with ensuring the safety of foods and medications sold to consumers in the U.S.—received hundreds of complaints about EpiPens, including complaints about the EpiPen failing. Who’s liable after an EpiPen failure and how do i go about filing a claim? Read on to learn more about EpiPen failures and liability law from our experienced product liability attorneys at Jacoby & Meyers, LLP.

How the EpiPen Works

EpiPen Failure ClaimEpinephrine auto-injectors inject a premeasured dose of epinephrine directly into the body. Epinephrine reverses anaphylaxis symptoms by causing the blood vessels to constrict and relaxing airway muscles. The injector is designed for the most rapid delivery possible, with ejection taking place in the thigh, through clothing if necessary.

The Types of EpiPen Failures That Can Occur

The most common EpiPen failures occur either when the injector needle deploys too early, or the injector needle becomes clogged. In the first example, the contents spill without delivering the vital hormone to the victim. In a clogged needle, the medicine may not dispense at all or in too small a dose to effectively treat the reaction.

What Happens When an EpiPen Fails?

As noted by the FDA, “If a person is experiencing an allergic reaction and anaphylaxis and cannot access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death.”

Those who survive despite the device failure face serious, life-altering implications.

Often, when the FDA receives several similar complaints about a product, they will begin an investigation into the product. If the complaints are valid, the manufacturer will often voluntarily recall the product, with the FDA assisting in administering the recall.

A product recall will notify consumers, who will obtain instructions on whether to stop using the product or how to get a replacement or repair to make the product safe. The company may also face legal claims from those who suffered injury or loss due to the defect.

Three types of defects can result in a product liability claim. Defects involving the product’s design often affect every lot of the product produced using that design. When recalls only list certain lots of a product, a manufacturing error may have caused the defect.

If a recall involves a problem with the product’s labeling—such as the failure to include instructions or disclose known risks of using the product—the product may undergo required changes to the packaging label to include that information.

Here is a look at some of the issues that can occur due to an EpiPen failure.

Health Complications To EpiPens

The most serious complications from an EpiPen failure involve the individual’s inability to treat a severe allergic reaction quickly. This can result in anaphylaxis, which occurs when the body’s immune system overreacts to an allergen, resulting in inflammation of the airway, which can cause the sufferer to have difficulty breathing. This overreaction also can cause a widening of the blood vessels, resulting in low blood pressure.

Some of the symptoms of anaphylaxis include:

  • Difficulty breathing
  • Suddenly feeling too warm
  • A skin reaction, such as hives or flushed skin
  • Nausea, vomiting, or diarrhea
  • A swollen tongue or lips
  • A runny nose and sneezing
  • Tingling hands, feet, or scalp
  • A feeling that something is wrong
  • Sudden dizziness or confusion

Failing to promptly treat anaphylaxis with an EpiPen and a follow-up visit to the emergency room can lead to serious or even fatal complications. Some of the complications of anaphylaxis include brain damage from lack of oxygen, kidney failure, the inability of your heart to pump enough blood to all parts of the body, an irregular heartbeat, heart attack, or death.

Financial Implications

Individuals who have sustained an injury due to a defective EpiPen that failed to provide needed medication can face several financial burdens. These financial implications include medical expenses, lost wages due to missed work, and the loss of future earning capacity due to complications of anaphylactic shock.

Affecting the Sufferer’s Quality of Life

Having a serious medical issue such as the potential for anaphylaxis is serious enough for many allergy sufferers to carry an EpiPen wherever they go. However, having a serious medical issue such as heart problems, kidney failure, or brain damage can result in lifelong impacts, including pain and suffering, emotional distress, loss of income, and loss of the ability to enjoy life.

Should I Contact a Lawyer After My EpiPen Injury?

Last year, court documents revealed that Mylan, the manufacturer of the EpiPen brand, had increased the cost of its medication from slightly over $100 for a two-pack to more than $600. At the same time, the company was reportedly making large political donations to U.S. Sen. Joe Manchin, who happened to be the father of Mylan’s CEO.

If pharmaceutical companies fail to invest their profits into the quality of their product and the safety of consumers, they will wind up investing their profits into paying claims filed against them by injured consumers or the family members of those who died while using it.

A product liability lawyer’s goal is to act in their client’s best interest. It is not the attorney’s job to make the important decisions about the claim, such as filing a personal injury lawsuit or accepting an offered settlement. Instead, they search for the best ways to help their client obtain the compensation they need after becoming injured due to a product defect. Here are some of the services that a product liability lawyer can provide you.

Investigating an EpiPen Claim

If a defective EpiPen injured you or took a loved one, your attorney will investigate to determine the source of liability and the liability insurance resources associated with the at-fault party that can provide your compensation. Additionally, your product liability lawyer will also seek evidence and witness testimony that proves the elements of your claim.

The elements your lawyer must prove in a product liability claim include:

  • The consumer used the product as directed.
  • The product was defective.
  • The consumer suffered an injury or death.
  • The product’s defect was the cause of the injury or death.

Product liability is usually a strict liability claim, unlike other personal injury claims like car accident claims. This means that the claimant does not need to prove that the manufacturer was negligent, only that the product was defective and resulted in injury.

Your attorney will also collect documentation to prove your expenses and establish a value for your claim based on several factors. Those factors include how severely you were injured, the actual expenses you incurred, and the amount of compensation available through the manufacturer or their insurance.

Filing an Defective Epipen Claim

Most plaintiffs file product liability claims against the manufacturer directly or against the insurance policy of the at-fault manufacturer.

When the at-fault party or their insurance provider receives the claim, they have three options:

  1. Accept liability for the injury or death and pay the claim in full.
  2. Deny liability for the injury or death that occurred and notify the claimant of the reason for the denial.
  3. Offer an out-of-court settlement for less than the full amount of the claim.

One thing that makes product liability claims complex is that they often affect hundreds or even thousands of people. Because of this, it is not unusual for numerous cases with similar claims of fact against a manufacturer to be joined—at least temporarily—to move these claims through the legal process more efficiently.

If the manufacturer faces a class action or multi-district litigation for the same issue that caused your injury or loss, your attorney will understand the implications on your claim.

Negotiating a Settlement for your EpiPen Case

If the at-fault party offers an out-of-court settlement in the matter, do not be surprised if their initial offer is far below the value of your claim. They almost always are, and your attorney will then work on negotiations to get them to increase their offer. However, whether to accept a settlement is always your decision. Your attorney can help you understand the value of your claim and the offer before you decide. Your product liability lawyer can also inform you about your settlement payout timeline.

Assisting You in Collecting Your Compensation or Award

Whether your case is tried singly in the state where you reside or as part of a more significant case against the manufacturer, after the case is complete, your attorney will help you collect your compensation. Additionally, because product liability cases sometimes result in a defendant appealing the verdict, your attorney will continue to represent you if necessary.

Yes, You Can Afford an Experienced EpiPen Lawyer

Andrew Finkelstein Jacoby & Meyers LLP

Auto Accident Lawyer, Andrew Finkelstein

The portrayal of legal matters on television or in the movies almost always involves a dramatic courtroom battle in which the defendant has the opportunity to make an impassioned speech to win over a jury. While this makes for interesting watching, it also seems expensive. In addition to the reality that most personal injury claims resolve outside of court, many people don’t know that everyone can afford an experienced lawyer.

Free Case Evaluations For EpiPen Victims

Most attorneys who work on product liability claims provide free case evaluations for those interested in their services. The case evaluation is an obligation-free opportunity for individuals to have an attorney look at their claim and determine if they have a case. The potential claimant can also learn more about the claims process and the law firm’s services.

Contingency-Fee Billing

In addition to providing free case evaluations, most attorneys also use a contingent-fee billing method. This means that the client does not have to pay for their legal team’s services until there is a positive outcome to the claim. Instead, the law firm receives a percentage of the settlement or court award after the case.

An agreement that the attorney and client enter into when they begin working together spells out the details of this arrangement. It will include the exact percentage the attorney will receive, the services the lawyer will provide, and any other debts that the attorney agrees to pay, such as liens placed on the award by hospitals or insurance groups.